On March 25^th, 2022, Qualtech held an online seminar to introduce Japanese health authorities’ requirements on technical data, which can be submitted during PMDA/RCB’s approval process. In this article, we would like to discuss some of the most important points presented in the webinar and bring you some insights on less challenging registration routes for foreign manufacturers, who are planning to enter the Japanese market.

The following is a summary of what this article entails:

1. 1. Requirements on biocompatibility tests
2. 2. Medical devices that require clinical trial data
3. 3. Acceptance of overseas clinical trial data
    

1. Requirements on Biocompatibility Tests:
Once you have found out that your medical device needs to show biocompatibility test results, the first thing you need to check is which testing facility the biocompatibility test was/will be done at.

The Japanese health authorities require biocompatibility tests to company with the Japanese GLP Ordinance. This means that when you submit biocompatibility test results, two things must be presented to PMDA or the RCB in order to show compliance: (1) a GLP Certificate issued by PMDA or a government body who has participated in the OECD and (2) a GLP compliance statement.

Because Japan is a member country of OECD (Organization for Economic Co-operation and Development), the Japanese health authorities accepts biological safety reports of other OECD member countries as well as non-member countries who adhere to OECD’s system of mutual acceptance of data.

Here are some examples of countries Japan accepts biocompatibility result from:

• OECD members:
  Most of the EU countries, Canada, the USA, Australia, New Zealand, Korea, Israel etc.
• Non-OECD member countries but adheres to OECD:
  South Africa, Singapore, Thailand, India, Brazil, and Malaysia

Please be careful that there are some OECD countries who did not pass OECD’s evaluation. This means that Japan is not obliged to accept data from these countries.


2. Medical Devices that Require Clinical Trial Data:
One of the most frequent questions Qualtech receives is in what occasion clinical trial data is required when entering the Japanese market. Here are some important aspects you can check to see if clinical data is a must to submit to PMDA.

1. 1) Medical device that does not have technical standards or Criteria.
   • Many of the existing medical devices in Japan are given medical device generic names, definitions, and technical standards to comply. Out of these devices who have generic names, some of them are not given technical standards.
     In this case, it is desirable to prove with non-clinical data that there is no gap from the existing device (predicate device) in terms safety and quality so as to omit submission of clinical trial data.
   • For those products that do not have generic names, the same strategy as above applies.
   • Please be noted that it is required to consult with PMDA about technical requirements and about the registration route when a medical device is not given technical standards or Criteria itself.
      
2. 2) Medical devices that are given specific notice

Some of the high-risk medical devices with Criteria or generic names are assigned with specific notices by the Japanese health authorities to announce special cases when requiring submission of clinical trial data. The following are some examples of such devices:

• • Coronary stent
  • Orthopedic implants
  • Laser-based medical devices
  • Contact Lenses

Many of the notices address that devices of non-conventional material and/or non-conventional intended use require clinical trial. If you would like a further guide on confirming the details of the notices, please contact Qualtech at your earliest convenience.

 

3. Acceptance of Overseas Clinical Trial Data:
When you have determined that your medical device indeed needs to submit clinical data, you might wonder if overseas data can be presented. The answer to this question is yes. PMDA accepts overseas clinical data; however, there are several things that must be confirmed, such as:

1. 1. The GCP or equivalent regulation is equivalent or stricter than JP GCP such as ISO: 14155:2020.
2. 2. Essential documents pertaining to GCP are prepared for document-based/on-site inspection.
3. 3. Cooperations are obtained from the sponsor of the clinical trial, the medical institution where the clinical trial is conducted, and other parties involved in the clinical trial.
4. 4. The reliability of the clinical trial as a whole is assured by the applicant through audits or other methods.
5. 5. If the standards of the country/region where the trial is conducted require a higher level of protection of patient than that of JP GCP, the standards must be followed.

Although overseas data can be used for PMDA submission, it is recommended by PMDA to have a consultation with the PMDA staff to nail down medical device approval. If you need any assistance regarding the consultation or registration route for your device, do not hesitate to contact Qualtech at any time.